AzTrials
AzTrials

Prostate CancerPhase 2PIVOTALNCT01685190

A Study of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer

A Phase 2 study testing Prostate alone IMRT and Prostate and pelvis IMRT in people with Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 7 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Prostate cancer is the most common male cancer in the UK with 35,000 cases diagnosed annually. 35% of these are locally advanced disease. These patients have a high chance of pelvic lymph node involvement and have relatively poor prostate cancer survival rates of 22.5% at 10 years. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Prostate alone IMRT and Prostate and pelvis IMRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
7 sitesUnited Kingdom
Study dates
Jun 2011to Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, non-metastatic adenocarcinoma of the prostate, previously untreated (other than by neoadjuvant hormonal treatment)
  • National Collaborative Cancer Network locally advanced disease (T3b± or T4)43 or:
  • Estimated risk of pelvic lymph node involvement ≥30% * and either:
  • Gleason 9 or 10 or
  • Gleason 8 and one other high risk feature (T3± disease or PSA >20) or
  • Gleason 7 and 2 high risk features (T3± disease and PSA ≥30)
Show all 14Show fewer
  • WHO performance status 0 or 1
  • Normal blood count (Hb > 11g/dl, WBC >4000/mm3, platelets >100,000/mm3)
  • LHRH analogue therapy for 6-9 months duration prior to proposed radiotherapy treatment and PSA < 4ng/ml prior to randomisation.
  • Age ≥ 18 years
  • Patients must be prepared to attend follow up. All patients participating in the Patient Reported Outcomes (PRO) Study must have adequate cognitive ability to complete the PRO questionnaires.
  • Written informed consent
  • T3a disease should be demonstrated convincingly, either clinically or by MRI. T3b disease (seminal vesicle involvement) must be convincingly demonstrated on MR.
  • Risk of pelvic lymph node involvement = (Gleason score - 6) x 10 + 2/3 PSA

Who cannot join

  • Prior pelvic radiotherapy
  • Prior major pelvic surgery (e.g. colectomy, colostomy, cystectomy, prostatectomy)*
  • Radiologically suspicious (short axis diameter ≥1.0cm unless biopsied and negative) or pathologically confirmed lymph node involvement
  • Life expectancy < 5 years
  • Castrate resistant prostate cancer (rising PSA after LHRHa and anti-androgen)
  • Previous active malignancy within the last 5 years other than basal cell carcinoma
Show all 9Show fewer
  • Co-morbid conditions likely to impact on the decision to treat with radiotherapy (e.g. previous inflammatory bowel disease, previous colo-rectal surgery, significant bladder instability or urinary incontinence)
  • Bilateral hip prosthesis or fixation which would interfere with standard radiation beam configuration
  • Patients who have undergone minor pelvic surgery will be eligible (eg appendicectomy, trans urethral resection of prostate (TURP), exploratory laparoscopy, haemorrhoidectomy, inguinal/femoral hernia repair)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United Kingdom7 sites

  • Queen Elizabeth

    Birmingham

  • Addenbrooke's Hospital

    Cambridge

  • Velindre Hospital

    Cardiff

  • Ipswich

    Ipswich

  • Clatterbridge Centre for Oncology

    Liverpool

  • Royal Marsden NHSFT

    London

  • Freeman Hospital

    Newcastle

Other trials in United Kingdom

About this study

Official title: A Randomised Phase II Trial of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer

Prostate cancer is the most common male cancer in the UK with 35,000 cases diagnosed annually. 35% of these are locally advanced disease. These patients have a high chance of pelvic lymph node involvement and have relatively poor prostate cancer survival rates of 22.5% at 10 years.

One of the standard treatments for these patients is radiotherapy to the prostate. PIVOTAL is a multi-centre phase II non-comparative randomised feasibility trial, in which patients with a high chance of pelvic lymph node involvement are randomised between prostate radiotherapy alone and prostate + pelvic radiotherapy.

Read more

Both groups will receive radiotherapy called Intensity Modulated Radiation Therapy (IMRT). This is a relatively new method of shaping radiotherapy treatment beams which allows the tumour to be treated more precisely, whilst avoiding more of the surrounding normal, healthy tissues (particularly the rectum, bladder and bowel). Using IMRT, it is possible to deliver higher doses of radiotherapy to the pelvis than with previous radiotherapy methods - this has been tested in a single hospital, single group setting and levels of side effects (toxicity) were acceptable.

PIVOTAL aims to find out whether toxicity levels at 18 weeks from the start of radiotherapy remain acceptable when treatment is given in multiple cancer centres across the UK. It is randomised to ensure unbiased collection of acute toxicity data and to provide information on patients' willingness to participate in a randomised study. Should the phase II study be successful, the investigators would develop a phase III trial to compare treatment effectiveness (disease control).

Patients who enter PIVOTAL will be followed up for two years from the start of radiotherapy and data relating to toxicity will be collected. They will also be asked to complete patient related symptoms questionnaires. Data related to disease recurrence will then be collected annually from patients' standard hospital visits.

Conditions
Prostate Cancer
Being tested
Prostate alone IMRT, Prostate and pelvis IMRT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostate alone IMRTRadiation

    Participants will receive standard prostate IMRT of 74Gy in 37 fractions delivered over 7.5 weeks.

  • Prostate and pelvis IMRTRadiation

    Participants will receive prostate and pelvis IMRT with a dose of 74Gy in 37 fractions delivered over 7.5 weeks to the prostate and 60Gy in 37 fractions delivered over 7.5weeks to the pelvis.

Study groups in NCT01685190
Study groupRoleWhat they receive
Prostate Alone IMRTActive comparatorParticipants will receive standard prostate Intensity Modulated Radiotherapy (IMRT) of 74Gy in 37 fractions delivered over 7.5 weeks.
Receives: Radiation: Prostate alone IMRT
Prostate & Pelvis IMRTExperimentalParticipants will receive prostate and pelvis IMRT with a dose of 74Gy in 37 fractions delivered over 7.5 weeks to the prostate and 60Gy in 37 fractions delivered over 7.5weeks to the pelvis.
Receives: Radiation: Prostate and pelvis IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute lower GI RTOG toxicity at week 18 of follow-up.

    Proportion of patients with acute GI RTOG grade ≥2 toxicity at week 18 from start of radiotherapy calculated as the number of patients with grade ≥2 toxicity at week 18 over the number of evaluable at week 18.

    Measured: 18 weeks post treatment

Secondary outcomes (7)

  1. Ability to deliver 60Gy in 37 fractions to the pelvis using the varying radiotherapy planning techniques and delivery systems at the participating centres.

    Measured: 2 yr

  2. Late (1 and 2 year) toxicity

    Measured using RTOG toxicity scale and CTCAE

    Measured: 2 yr

  3. Patient Reported Outcomes

    Participants are requested to complete questionnaires to record the impact of the treatments on bowel and bladder function.

    Measured: 2 yr

  4. Biochemical progression free survival

    Measured: 10 yr

  5. Time to local progression

    Measured: 10 yr

  6. Time to distant metastases

    Measured: 10 yr

  7. Overall survival

    Measured: 10 yr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2012 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2013
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685190
Sponsor's protocol ID
ICR-CTSU/2010/10025
Other IDs
CRUK/10/022, ISRCTN48709247
Acronym
PIVOTAL
Status last verified
Jan 2019
First submitted
26 Oct 2011
Last updated
4 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Harris VA, Staffurth J, Naismith O, Esmail A, Gulliford S, Khoo V, Lewis R, Littler J, McNair H, Sadoyze A, Scrase C, Sohaib A, Syndikus I, Zarkar A, Hall E, Dearnaley D; PIVOTAL Trialists. Consensus Guidelines and Contouring Atlas for Pelvic Node Delineation in Prostate and Pelvic Node Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):874-83. doi: 10.1016/j.ijrobp.2015.03.021. Epub 2015 Mar 30.

    PubMed 26104940

  • Dearnaley D, Griffin CL, Lewis R, Mayles P, Mayles H, Naismith OF, Harris V, Scrase CD, Staffurth J, Syndikus I, Zarkar A, Ford DR, Rimmer YL, Horan G, Khoo V, Frew J, Venkitaraman R, Hall E. Toxicity and Patient-Reported Outcomes of a Phase 2 Randomized Trial of Prostate and Pelvic Lymph Node Versus Prostate only Radiotherapy in Advanced Localised Prostate Cancer (PIVOTAL). Int J Radiat Oncol Biol Phys. 2019 Mar 1;103(3):605-617. doi: 10.1016/j.ijrobp.2018.10.003. Epub 2018 Dec 6.

    PubMed 30528653

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prostate alone IMRT and Prostate and pelvis IMRT in people with Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 7 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute lower GI RTOG toxicity at week 18 of follow-up. (time frame: 18 weeks post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01685190, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in